Expert Analysis

• Drug Ad Crackdown Demonstrates Admin's Aggressive Stance

  

  Recent actions by the U.S. Food and Drug Administration and U.S. Department of Health and Human Services targeting pharmaceutical companies' allegedly deceptive advertising practices signal an active — potentially even punitive — intent to regulate direct-to-consumer advertising out of existence, say attorneys at King & Spalding.

• Transmission Security Has A Critical Role In Healthcare

  

  In light of the U.S. Department of Health and Human Services' Office of Civil Rights' continuing enforcement initiative focusing on businesses' accurate and thorough security risk assessments under the Health Insurance Portability and Accountability Act, covered entities should not neglect the importance of transmission security, says John Howard at Clark Hill.

• When AI Denies, Insurance Bad Faith Claims May Follow

  

  Two recent rulings from Minnesota and Kentucky federal courts signal that past statements about claims-handling practices may leave insurers using artificial intelligence programs in claims administration vulnerable to suits alleging bad faith and unfair trade practices, say attorneys at Cozen O'Connor.

• DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

  

  The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

• New Colo. Teen Privacy Rules Signal National Regulatory Shift

  

  Recently released proposed rule amendments to the Colorado Privacy Act that would create some of the most robust protections for minors' online data in the U.S. reflect an ongoing trend of states taking steps to extend privacy protection for their residents, complicating the compliance burden for companies, say attorneys at Morgan Lewis.

• The Future Of Lab-Test Regs After FDA Rescinds Rule

  

  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

• How States Are Regulating Health Insurers' AI Usage

  

  The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

• Previewing State Efforts To Regulate Mental Health Chatbots

  

  New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

• How DOJ's New Data Security Rules Leave HIPAA In The Dust

  

  The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

• How The Healthline Privacy Settlement Redefines Ad Tech Use

  

  The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

• High Court Cert Spotlights Varying Tests For Federal Removal

  

  A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.

• IRhythm IPR Denial Raises Key PTAB Discretion Questions

  

  By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.